MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. CITADEL PLUS; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number FX811B3B4AMABB

Device Problem Use of Device Problem (1670)

Patient Problems Fall (1848); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/28/2022

Event Type  malfunction  

Manufacturer Narrative

The bed was checked by arjo service technician and no malfunction was found.The side rails locked correctly.The investigation conclusions will be provided to the follow-up report.

Event Description

It was claimed by the customer staff that a right side rail opened and a patient fell out from a citadel plus bed frame.No injury was claimed.

Manufacturer Narrative

Arjo received a customer complaint with an allegation of a patient fall from a citadel plus bed frame.The customer claimed that the patient¿s right side rail opened what resulted in the patient¿s fall from the bed frame.No injury was reported.The device evaluation conducted by the arjo representative following the event showed that the side rails lock correctly and no malfunction was found.The citadel plus instruction for use (831.374) instructs user to: ¿whether or how to use side rails (¿) is a decision that should be based on each patient¿s needs and should be made by the patient and the patient¿s family, physician and caregivers, with facility protocols in mind.Caregivers should assess risks and benefits of side rail (¿) (including (¿) patient falls from the bed) in conjunction with individual patient needs (¿).Consider not only the clinical and other needs of the patient but also the risks of fatal or serious injury from falling out of the bed (¿).¿ ¿make sure the locking mechanism is securely engaged when the side rails are raised.¿ additionally, the operation of the side rails should be checked daily by the device owner.If the malfunction is identified, arjo or an approved service agent should be contacted.Based on the device condition, it could be concluded that the side rail may not have been locked in the upright position therefore it opened unexpectedly.The training focusing on the side rail functionality was provided to the customer following the event.Arjo device was used for the patient treatment when the event occurred and played a role in the event.The side rail opened and from that perspective the citadel plus bed did not meet the performance specification.The complaint was assessed as reportable due to allegation of the patient¿s fall, which may lead to serious health consequences.

• Brand Name: CITADEL PLUS
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer Contact: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 16213615
• MDR Text Key: 308166727
• Report Number: 3007420694-2023-00011
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 05055982756532
• UDI-Public: (01)05055982756532(11)210409
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: FX811B3B4AMABB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female